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Session 2: Biosimilars During a Pandemic
Laura McKinley, PhD
- Director, Global Regulatory Policy and Intelligence
- Pfizer Inc, United States
As the world continues to navigate the COVID-19 pandemic what will the impact be to biosimilars? This session will discuss the ways biosimilar stakeholders are adjusting to the COVID-19 pandemic to navigate and execute in the new normal. Panelists will present the regulatory perspectives, customer view, and potential impacts to access and uptake.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize the short and long-term regulatory impacts of COVID-19 on biosimilar development and approvals
- Discuss the customer perspective of pandemic implications to biosimilar use
- Debate the short and long-term impacts of COVID-19 on access and uptake
Peter P. Stein, MD
- Director, Office of New Drugs, CDER
- FDA, United States
Sean McGowan, MBA
- Senior Director, Biosimilars
- AmerisourceBergen, United States
Juliana Marguerite Reed, MS
- Vice President, Corporate Affairs, Global I & I and Biosimilars Lead
- Pfizer, Inc., United States